The number of women considering legal action against Sanofi is quickly growing, as more patients learn about their legal right to seek compensation for hardship and loss. Hundreds of breast cancer survivors have already filed Taxotere lawsuits in federal district courts throughout the U.S.
Hair Loss Claims Consolidated In New Orleans
Today, over 1,500 of these Taxotere lawsuits are now consolidated in the US District Court for the Eastern District of Louisiana. In New Orleans, the cases have been moving through pre-trial proceedings as a group, allowing plaintiffs to collaborate in developing evidence and legal arguments.
And once all the evidence has been shared, a group of initial lawsuits will head to trial. District Judge Kurt Engelhardt, who has been selected to preside over the consolidated Multi-District Litigation, has scheduled four of these “bellwether” trials to begin in January of 2019.
According to these lawsuits, Sanofi has been putting cancer patients at risk for permanent alopecia without warning. Plaintiffs say the company deprived them of the opportunity to seek out alternative choices, like the closely-related drug Taxol, which appears to harbor no risk of permanent hair loss and is just as effective as Taxotere. The plaintiffs are each requesting over $75,000 in damages for being subjected to a “disfiguring” condition that they say could have been avoided if Sanofi had issued proper warnings.
A Closer Look At Allegations
In order to build a solid case against Sanofi, Taxotere plaintiffs, and their attorneys must demonstrate how the manufacturer’s actions (or lack of action) directly led to injury and loss. Let’s look over one of the lawsuits in detail to get a clearer view of the specific accusations raised in these lawsuits, along with the evidence presented to support them.
Carson Lawsuit: Standard Chemo, Lifelong Hair Loss?
Ohio resident Hattie Carson first found out that she had breast cancer on April 15, 2004, after an abnormal mammogram. Three weeks later, she underwent a lumpectomy and a sentinel node biopsy on her right breast. She and an oncologist then decided on an adjuvant chemotherapy regimen, which included the widely-prescribed drug Taxotere, as the next step in her treatment plan.
Carson says that neither she nor her doctors knew that Taxotere could cause permanent hair loss, because Sanofi didn’t provide any information about these risks at the time.
After receiving Taxotere, Carson discovered that she had developed permanent alopecia, and she says the condition caused her considerable physical, mental, and emotional suffering, as well as financial loss, both from decreased earnings and from counseling, therapy, and medical expenses resulting from her ordeal.
Arguments Supporting Carson’s Right To Compensation
In demanding compensation, plaintiffs must put forth specific reasons that the defendant(s) owe them relief and form arguments based on relevant legal theories. Hattie Carson’s lawsuit asserts 12 separate claims for relief, which include:
Defendants are said to be negligent if they cause injury to someone by performing their duties carelessly. In order for the legal theory of negligence to apply, the defendant(s) must have owed a responsibility to behave in a certain way toward the plaintiff(s) and have directly caused a plaintiff’s injury through their negligence. The standard for what counts as negligence is what a reasonably competent person with the same level of training or education as the defendant would do in the same situation.
Carson is accusing Sanofi of negligence because drug manufacturers have a responsibility to provide patients with reasonably safe products and to warn the public of side effects. She points out that Sanofi knew that Taxotere was more potent and likely more toxic than Taxol, and also knew about the increased incidence of certain side effects from early clinical trials.
She then asserts that any reasonable manufacturer seeking to uphold its duties to protect patients would have responded to this knowledge both by doing further research on the side effects of Taxotere and by making sure to inform doctors and patients of research findings as they become available.
Strict Product Liability
This legal theory says that manufacturers are liable for product defects even if they did their very best to exercise proper care and diligence in all the tasks they perform to bring products to market, including design, production, testing, distribution, sales, and advertising. Carson claims that Taxotere is defective in its:
- Design and Manufacturing. Carson says that Taxotere is “unreasonably dangerous” to patients compared to other similar drugs on the market.
- Failure to Warn. When Carson took Taxotere, its label did not include permanent hair loss warnings.
According to Carson, not only did Sanofi fail in its manufacturing responsibilities with Taxotere and fail to warn the public, the company intentionally skewed its public image of the drug, making it seem safer and more effective than it actually is, as demonstrated by research and postmarket surveillance.
More Litigation Against Sanofi
The recent wave of patient lawsuits isn’t the first time that Sanofi has come under fire for alleged misconduct with regard to Taxotere.
Sanofi Loses Patents Through “Inequitable Conduct”
In 2010, Sanofi lost two of its patents for Taxotere due to a court ruling by Judge Gregory Sleet, which said that the company was guilty of withholding information on patent applications.
In order to secure these patents, which would grant Sanofi the exclusive right to create drugs using Taxotere’s active ingredient and obtain billions of dollars in increased revenue, the company made the drug seem more “novel” by not including some previous references to its development. But after looking over the patent application and more information about the production of docetaxel, Judge Sleet decided that the patents were “unenforceable” because the creation of docetaxel was “obvious” after full consideration of previously-developed drugs.
This court ruling opened the door for the development of generic versions of docetaxel.
“Whistleblower” Suit Filed By Former Sales Rep
As the recent hair loss lawsuits explain, Sanofi had already been accused of Taxotere-related fraud in litigation initiated more than a decade ago. Back in 2001, the company faced a Qui Tam lawsuit—a complaint filed by a citizen “whistleblower” on behalf of the United States to recover funds stolen from the government –alleging that Sanofi had committed multiple types of marketing fraud to illegally obtain millions of dollars in reimbursement from government medical assistance programs.
Did Sanofi Promote Off-Label Use With Kickbacks?
According to the lawsuit, filed by Yoash Gohil, who worked as a sales representative in Sanofi’s Oncology Sales division for over 20 years, Sanofi ran a “fraudulent marketing scheme” from 1996 to 2002 which involved offering “illegal kickbacks” to medical professionals as incentives for promoting off-label uses and too-high doses of Taxotere. The company gave out these kickbacks to doctors, hospitals, pharmacists, and researchers in various forms, including:
- sham unrestricted grants
- free samples
- speaking fees
- travel and entertainment,
- sports and concert tickets,
- free reimbursement assistance
- preceptorship fees (in this case, sums of money Sanofi gave physicians to allow their sales reps to observe doctor-patient interactions)
In exchange for these items, Gohil said, doctors were persuaded to prescribe Taxotere for uses that had not yet been FDA-approved at the time or even those that were never approved at all. Back then, Taxotere was only approved for 2 or 3 indications, but doctors were giving the drug to patients for over 15 off-label indications.
Selling More Taxotere Through Higher Doses
Gohil claims that Sanofi didn’t stop at off-label prescriptions, but also influenced doctors to prescribe much higher dosages of Taxotere than was FDA-approved, just to sell more of the drug.
For example, instead of the approved 60-100mg per square meter of body area once every 3 weeks, doctors receiving kickbacks reportedly prescribed around 40 mg per sq. meter every week—effectively up to twice as much. Such high doses, Gohil speculated, may have led to increased incidence and/or severity of common Taxotere side effects, causing unnecessary discomfort or even harm to patients. This concern would later be echoed in patient lawsuits like Hattie Carson’s, which declares that Sanofi’s misconduct caused “thousands of individuals [to be] exposed to increased frequency and more severe side effects, including but not limited to disfiguring permanent alopecia.”
Misleading Advertising Called Out By FDA
In addition to providing potential customers with skewed summaries of relevant medical research, the complaint points out that the FDA itself had to step in multiple times to warn Sanofi about certain misleading advertisements and statements it was distributing.
But the big issue that FDA had with Sanofi’s Taxotere marketing campaign concerned a “gloss” that summarized a particular clinical trial saying that the results support Taxotere’s effectiveness. According to the FDA, the gloss overreached the actual study results, which didn’t actually reveal anything very positive for Taxotere. Thus the summary provided by Sanofi was misleading to readers and the FDA demanded that Sanofi stop using any printed materials using the summary. However, Sanofi ignored these FDA warnings and continued to use the gloss, as evidenced by the FDA sending a second warning letter regarding these materials.
Millions Of Dollars In Increased Revenue
Many patients depend on the assistance of government programs like Medicare and Medicaid to help them afford expensive drugs like Taxotere, which at the time cost about $15,000 per patient. Gohil believes that illegal claims filed by healthcare providers under the “corrupt influence” of Sanofi played a large part in enabling the company to earn over $814 million from Taxotere sales in 2001, a figure that more than doubled by 2004 when Sanofi reportedly earned over $1.75 billion from Taxotere.
Gohil also says that Sanofi attempted to conceal its alleged fraud through “false and misleading statements to the public, healthcare providers, and the FDA,” and even instructed its employees to hide evidence whenever possible.
Qui Tam Suit Still Pending Despite Sanofi’s Efforts
Though Gohil’s lawsuit was originally filed on May 17, 2002, in the US District court for the Eastern District of Pennsylvania, it has been dismissed and re-submitted several times since. Predictably, Sanofi filed a motion to get the case dismissed, but Judge Lawrence Strengel permitted Gohil to file again on March 30, 2015, and this latest version of the complaint is still pending in court.
Patients Have A Right To Know
Risk-benefit considerations for chemotherapy are often complex. It’s certainly possible that some women would have chosen Taxotere, even if they’d been aware of its permanent hair loss risks if the drug offered the best chance of effective treatment.
The fact remains, however, that these women had the right to know – they had the right to be given relevant information that would help them make the best decision for their long-term well-being. But the Taxotere plaintiffs feel that their freedom of choice was stolen from them, and they were unfairly subjected to risks they weren’t aware of.
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